See below for detailed specifications, pediatric applications, and FAQ.
Meatal stenosis; a narrowing of the urethral opening — is technically a form of urethral stricture, though in clinical practice the two terms are used distinctly: meatal stenosis refers specifically to the external urethral opening, while urethral stricture typically describes narrowing deeper within the urethral canal. Whether the obstruction is at the meatus or proximal to it, progressive dilation with a purpose-built instrument is the first-line, non-surgical intervention.
The ACE Medical Meatal Dilator is engineered for exactly this indication. Its tapered hydrophobic polycarbonate tip advances smoothly through stenotic tissue to restore adequate luminal caliber, reduce post-void dribbling, and re-establish normal urinary flow; in both adult and pediatric patients.
Patients should never order a Meatal Dilator from unregulated online marketplaces. These are Class II medical devices that require a physician prescription. Products sourced from sites such as eBay or Amazon; particularly those shipping from overseas, may not meet sterilization or material standards, and unverified seller claims cannot be trusted with your health. Use our secure order form: provide your doctor’s office contact details and we work directly with your healthcare provider to dispense compliant product. Learn more about safe sourcing here.
The dilator’s precision taper allows progressive, atraumatic stretching of the urethral meatus in a single, controlled pass. The hydrophobic surface coating minimizes mucosal adherence, reducing friction on insertion and withdrawal. Unlike stainless-steel dilators, the medical-grade polycarbonate construction is firm enough to transmit dilating force while remaining smooth and non-abrasive against sensitive tissue.
Each unit is individually packaged in a sterile peel-open pouch. Single-use eliminates the risk of cross-contamination, requires no additional sterilization cycle, and integrates seamlessly into standard outpatient and ambulatory surgical workflows.
Meatal stenosis is disproportionately common in circumcised male infants and boys, often presenting as a thin, misdirected urinary stream. The Meatal Dilator is suitable for use in pediatric patients under urologist or pediatric urology supervision. Its gentle taper and controlled engagement allow precise dilation at smaller meatal diameters without requiring surgical meatotomy in many cases. Consult the treating urologist for appropriate sizing and technique.
Manufactured in the Netherlands in full compliance with ISO 13485:2016 medical device quality management standards and FDA registered, every unit undergoes rigorous process controls before leaving the facility. ACE Medical Co. supplies it in the US under our ISO 13485 certified quality management system; documentation available on our Certifications page.
What is the difference between meatal stenosis and a urethral stricture?
Meatal stenosis is a narrowing at the external urethral opening (the meatus). A urethral stricture generally refers to scar tissue narrowing within the urethral canal, beyond the visible meatal opening. Meatal stenosis is technically a subtype of urethral stricture but is managed differently — typically with dilation or minor meatotomy rather than internal urethrotomy or urethroplasty.
Can patients perform meatal dilation at home?
Home dilation is sometimes prescribed by urologists for maintenance after initial clinical dilation. However, patients must only use devices prescribed and sourced through their healthcare provider. Never use unverified or non-sterile instruments.
Is this dilator suitable for pediatric patients?
Yes, under the supervision of a pediatric urologist or urologist. Meatal stenosis in pediatric males following circumcision is a recognized indication. Consult your specialist for guidance on technique and frequency.
What quantities are available?
The Meatal Dilator (model MD6/16) is available in packs of 1, 5, 10, 50, and 100 units. Use the Request a Quote option above or contact us for volume pricing and distributor inquiries.
Is the Meatal Dilator FDA approved or FDA cleared?
It does not need FDA approval or 510(k) clearance. Urethral dilators are Class II devices that FDA exempts from premarket notification. The MD6/16 is listed with FDA in the Global Unique Device Identification Database (GUDID) as a single use urethral dilator, product code KOE, marked prescription only. You can look it up yourself. ACE Medical Co. lists it as GUDID record 00840217910002, and the manufacturer, MED pro Medical B.V., lists it as GUDID record 08718455508270.
Who makes this meatal dilator?
MED pro Medical B.V. in the Netherlands, a global leader in meatal and urethral dilators. ACE Medical Co. sources it directly and supplies it to US hospitals, urology practices and prescribing physicians.
Is a meatal dilator prescription only?
Yes. The manufacturer’s FDA listing marks it prescription only. Patients doing home dilation should get the device through their urologist or with a prescription, and ACE works with the prescribing office to supply it.
Why not buy a meatal dilator on eBay or Amazon?
Many dilators sold online ship from overseas makers with no FDA device listing, no GUDID record and no sterilization or material validation records. Sellers there often ship straight to patients with no quality oversight. Before you use any dilator, check that it has a GUDID record and comes from a supplier that can show its documentation.
What sizes does it cover?
One dilator covers 6 to 16 French (Fr) in a single tapered device, 9 cm long, sterile and single use.
Ready to order?
Scroll up to request a quote, or contact us for bulk orders, distributor pricing, and clinical support.
| Quanttiy MD6/16 | 1, 5, 10, 50, 100 |
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